Junk-science

Why are we tolerating the use of junk science against those in the medical profession? A direct question that begs for a direct answer.

mllangan1 7 Comments
 “That everyone shall exert himself in that state of life in which he is placed, to practice true humanity towards his fellow men, on that depends the future of mankind.” – Albert Schweitzer 
“By and by never comes” –St Augustine

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“A day’s impact is better than a month of dead pull”-Justice Oliver Wendell Holmes, Jr.

 I am looking for a few honest and credible statisticians, biostatisticians or epidemiologists who want to make a difference in the spirit  of service and helping others.  I can’t pay you but you would be combating injustice, corruption and dishonesty.   You would be doing your part in helping the Medical Profession, honest and decent doctors, our country and  perhaps our future.  

It is only a few public policy steps and minor changes in state regulatory statutes before what is described in the ASAM White Paper on Drug Testing comes to fruition.  Before we know it the Drug and Alcohol Testing Industries “New Paradigm” as described here by Robert Dupont will be ushered in as it did with doctors; not with a bang but a whimper.  From the ASAM white Paper:

“THIS WHITE PAPER ENCOURAGES WIDER AND “SMARTER” USE OF DRUG TESTING WITHIN THE PRACTICE OF MEDICINE AND, BEYOND THAT,BROADLY WITHIN AMERICAN SOCIETY. SMARTER DRUG TESTING MEANS INCREASED USE OF RANDOM TESTING* RATHER THAN THE MORE COMMON SCHEDULED TESTING,* AND IT MEANS TESTING NOT ONLY URINE BUT ALSO OTHER MATRICES SUCH AS BLOOD, ORAL FLUID (SALIVA), HAIR, NAILS, SWEAT AND BREATH WHEN THOSE MATRICES MATCH THE INTENDED ASSESSMENT PROCESS. IN ADDITION, SMARTER TESTING MEANS TESTING BASED UPON CLINICAL INDICATION FOR A BROAD AND ROTATING PANEL OF DRUGS RATHER THAN ONLY TESTING FOR THE TRADITIONAL FIVE-DRUG PANEL.”

To prevent this future drug testing dystopia, that includes testing schoolchildren, we need to take a step back and analyze the reliability and credibility of the “evidence-base” behind these multiple non-FDA approved forensic drug and alcohol tests and testing devices the ASAM proposes be used on the population at large utilizing the Medical Profession as a urine collection agency and bypassing forensic drug testing protocol by calling this “evaluation” and treatment rather than “monitoring” and punishment. New definitions, loopholes, secrecy and subterfuge are the bread and butter of these prohibitionist profiteers.

Amazingly, there has been no Academic review of these tests, let alone a Cochrane type critical analysis.  It is essentially untapped territory.  In addition there has been no Institute of Medicine type Conflict of Interest Analysis.  And that is why I am asking for help from statisticians, biostatisticians and epidemiologists.  The task would entail a review of the literature prior to the introduction of these tests for evidence base of forensic applicability (there essentially is none) and a review of the literature peri-and post marketing of these devices to assess the reliability and credibility of the underlying methodology and ascertain the evidence-base.  The goal would be publication in both academic journals and presentation to the general public through media publication with the assistance of investigative journalists and other writers. The goal is to get the truth out about these tests and allow both the medial profession and public at large to awaken to the menace this presents to medicine, our society and our future.

 Lack of Evidence-Base, Bias and Conflicts of Interest:  Making the Data Fit the Hypothesis

I am no epidemiologist or statistician but as with pornography I know junk-science when I see it.  Almost all of these tests were introduced with little or no evidence-base and, as with most of their endeavors, they did it below board via loopholes and cutting corners.

The overwhelming majority of papers are small, methodologically flawed, non-randomized, non-blinded  retrospective studies in that appear to make the data fit the hypothesis.   The authors can invariably be linked to those profiting from the tests of the testing process ( the patent holder, doctors associated with the drug testing labs, ASAM or FSPHP, Robert Dupont, Greg Skipper, etc.)

 

Ethyl Glucuronide (EtG) was introduced in 1999 as a biomarker for alcohol consumption,1 and was subsequently suggested as a tool to monitor health professionals by Dr. Gregory Skipper because of its high sensitivity to ethanol ingestion.2   

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Described as the  “innovator of EtG as an alcohol biomarker,” Skipper and  Friedrich Wurst,  “convinced” NMS labs in Pennsylvania “to start performing EtG testing in 2002.

The study most often cited as 100% proof that there is 100% accuracy in EtG testing proving alcohol consumption involved a mere 35 forensic psychiatric inpatients in Germany that was published in 2003.3  

Shortly thereafter the Physician Health Programs began using it in monitoring doctors and other professional monitoring programs soon followed.

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Up until the birth of the EtG tests used for forensic drug and alcohol monitoring had to go through the arduous, expensive and necessary FDA approval process.   The LDT pathway was designed to develop simple tests with little risk that have  low market potential (i;e. the cost of the normal FDA approval process would prohibit them from coming to market).  The LDT pathway was designed to improve patient care and help improve diagnosis and treatment. It was not designed for forensic tests.  LDT approval does not require in vivo testing.  It is essentially an honor system and to develop an LDT it is not even necessary to prove that the test is actually testing what it is purportedly testing for (validity).

So with little to no evidence base they introduced the EtG, had it developed and marketed as a LDT in collusion with unscrupulous labs, and then began using it on physicians being monitored by State PHPs. This then spread to other monitoring organizations in which there was a large power-differential between those ordering the tests and those being tested (criminal-justice, other professional monitoring programs).  These biomarkers have never been used in Federal Drug Testing, SAMHSA approved, DOT, and other organizations where unions or other organizations are present and looking out for the best interests of those being tested.

Another example of how this group removes accountability.  There has been essentially no oversight or regulation of LDTs.  Although there was a recent push for regulation of these tests the Drug and Alcohol Testing Industry Association lobby made sure that forensic tests would be exempt.

They then began publishing “research” on the EtG using the physicians being monitored as subjects. Many of the studies promoting the EtG and other biomarkers can be found  in  Journals that are linked to organizations that are linked to AA and were organized to educate the medical community.

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These small, methodologically flawed studies amount to little more than opinion pieces but   This “evidence-base” is predominantly in biased journals published by biased medical “societies.  
The EtG was subsequently found to be so sensitive that it could measure incidental exposure to alcohol in foods, over the counter cold medications, mouthwash4,5, hand sanitizer gel6, nonalcoholic beer7, and nonalcoholic wine.8  Sauerkraut and bananas have even been shown to cause positive EtG levels.9
The United States Substance Abuse and Mental Health Services Administration warned against using a positive EtG as primary or sole evidence of drinking for disciplinary or legal action.10  The Wall Street Journal in 2006 reported the problems with the EtG to the general public.11   
Screen Shot 2014-03-23 at 10.45.36 PMAs any rational authority would do, the majority of monitoring agencies abandoned the EtG after these flaws were revealed. The PHPs did not.  They continued to use the EtG on doctors uninterruptedly by telling them to avoid any products that could potentially contain alcohol; a ubiquitous substance in the environment. Since that time they have justified and rationalized (EtG)2,12 13  use by sequentially raising cutoff levels from 100 to 250 to 500 to 1000 to 2000 to now unknown and adding other LDTs as “confirmation tests such as Ethyl Sulfate (EtS)14,15 Phosphatidyl-Ethanol ( Peth)16 17 and other devices such as the Subcutaneous Remote Alcohol Monitoring Bracelet (SCRAM) and, their newest device the Cellular Photo Digital Breathalyzer (CPDB) that has recently been launched, just like the EtG Screen Shot 2014-02-23 at 10.00.22 PMwith little to no evidence base other than a pilot study done by Greg Skipper and Robert Dupont.18 
A  2013 article published in an ASAM incubated journal Alcoholism: Clinical and Experimental Research promotes the Phosphatidyl-ethanol (PEth ) test to confirm drinking.16  The study was done on physicians being monitored by the Alabama Physician Health Program who tested positive for EtG/EtS alcohol biomarkers. It is co-authored by Robert Dupont, Greg Skipper, and Friedrich Wurst and involved 18 subjects who tested positive for EtG/EtS of whom 7 claimed they did not drink.  After finding that 5 of the 7 tested negative for PEth they concluded that “positive PEth testing following positive EtG/EtS results confirms recent drinking.  Hard to wrap your head around the science in that one.Screen Shot 2014-04-30 at 1.06.53 PMSkipper is also using both Scram ankle bracelets and the CPDB monitoring in pilots in the Human Interventional Motivational Study (HIMS) Program that was developed in 2009 to “identify, treat and, eventually, re-certify airline pilots with substance abuse problems. 
 
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The Cochrane Collaboration does systematic reviews of the literature using conscientious, explicit, and judicious criteria to in order to produce and disseminate only high quality and evidenced based health care, exclude bias, and enhance transparency. The Cochrane database is a current and evolving database that includes the accuracy of diagnostic tests and is internationally recognized as the standard in evidence based health care.  This benchmark for evidence based health care and systematic reviews, records just 5 controlled trials under the topic ethyl glucuronide.8,19-21 These 5 studies represent the only high-quality evidence regarding EtG applying to EtG. Information provided by the five studies suggests the following, and only the following:

  1. EtG and EtS measurements increase with alcohol ingestion.
  2. The window of detection is shorter than what is commonly proposed (80 hours).
  3. Individual values are variable both within and between subjects.
  4. Non alcoholic wine can cause positive levels.

Notably, there are no studies that fit Cochrane Criteria, other than non-alcoholic wine, that look at the pharmacokinetics of EtG or EtS in terms of dose-response curves, cut-off levels, specificity drug and food interactions, or modes of ingestion.

SAMHSA notes that there is little research on PEth and that EtG, EtS, and PEth “do not have a strong research base,” and that “it is not known at this time how the test results might be affected by the presence of physical diseases, ethnicity, gender, time, or the use of other drugs. Until considerable more research has occurred, use of these markers should be considered experimental.”

Phosphatidylethanol (PEth), SCRAM, and the  yields no data as a test in the Cochrane library.

SAMHSA notes that there is little research on PEth and that EtG, EtS, and PEth “do not have a strong research base,” and that “it is not known at this time how the test results might be affected by the presence of physical diseases, ethnicity, gender, time, or the use of other drugs. Until considerable more research has occurred, use of these markers should be considered experimental.”

Evidence based medicine (EBM) can be defined as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.22

Medical progress and scientific advancement is occurring so fast that the volume of medical literature is expanding at a rate of greater than 7% per year.23

Evidence based medicine is not restricted to randomized trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions.22  

Expert opinion is the lowest level of evidence available in the EBM paradigm.24,25

Fortunately, the scientific method is a tool to help people progress toward the truth despite their susceptibilities to confirmation bias and other errors.26

Unfortunately, due to a confluence of factors (including political) this has not been done.  But, unless we want a  future as envisioned by Robert Dupont and explained in the the ASAM White Paper on Drug Testing we need to act now.  This is not a “New Paradigm” but a “New Inquisition.”

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  1. Wurst FM, Kempter C, Seidl S, Alt A. Ethyl glucuronide–a marker of alcohol consumption and a relapse marker with clinical and forensic implications. Alcohol Alcohol. Jan-Feb 1999;34(1):71-77.
  2. Skipper GE, Weinmann W, Thierauf A, et al. Ethyl glucuronide: a biomarker to identify alcohol use by health professionals recovering from substance use disorders. Alcohol Alcohol. Sep-Oct 2004;39(5):445-449.
  3. Wurst FM, Vogel R, Jachau K, et al. Ethyl glucuronide discloses recent covert alcohol use not detected by standard testing in forensic psychiatric inpatients. Alcohol Clin Exp Res. Mar 2003;27(3):471-476.
  4. Costantino A, Digregorio EJ, Korn W, Spayd S, Rieders F. The effect of the use of mouthwash on ethylglucuronide concentrations in urine. J Anal Toxicol. Nov-Dec 2006;30(9):659-662.
  5. Reisfield GM, Goldberger BA, Pesce AJ, et al. Ethyl glucuronide, ethyl sulfate, and ethanol in urine after intensive exposure to high ethanol content mouthwash. J Anal Toxicol. Jun 2011;35(5):264-268.
  6. Rosano TG, Lin J. Ethyl glucuronide excretion in humans following oral administration of and dermal exposure to ethanol. J Anal Toxicol. Oct 2008;32(8):594-600.
  7. Thierauf A, Gnann H, Wohlfarth A, et al. Urine tested positive for ethyl glucuronide and ethyl sulphate after the consumption of “non-alcoholic” beer. Forensic Sci Int. Oct 10 2010;202(1-3):82-85.
  8. Hoiseth G, Yttredal B, Karinen R, Gjerde H, Christophersen A. Levels of ethyl glucuronide and ethyl sulfate in oral fluid, blood, and urine after use of mouthwash and ingestion of nonalcoholic wine. J Anal Toxicol. Mar 2010;34(2):84-88.
  9. Musshoff F, Albermann E, Madea B. Ethyl glucuronide and ethyl sulfate in urine after consumption of various beverages and foods–misleading results? Int J Legal Med. Nov 2010;124(6):623-630.
  10. Administration SAaMHS. The role of biomarkers in the treatment of alcohol use disorders. In: Advisory SAT, ed2006:1-7.
  11. Helliker K. A test for alcohol–and its flaws. The Wall Street Journal2006.
  12. Wurst FM, Skipper GE, Weinmann W. Ethyl glucuronide–the direct ethanol metabolite on the threshold from science to routine use. Addiction. Dec 2003;98 Suppl 2:51-61.
  13. Wurst FM, Alling C, Aradottir S, et al. Emerging biomarkers: new directions and clinical applications. Alcoholism, clinical and experimental research. Mar 2005;29(3):465-473.
  14. Anton RF. Commentary on: ethyl glucuronide and ethyl sulfate assays in clinical trials, interpretation, and limitations: results of a dose ranging alcohol challenge study and 2 clinical trials. Alcoholism, clinical and experimental research. Jul 2014;38(7):1826-1828.
  15. Hernandez Redondo A, Schroeck A, Kneubuehl B, Weinmann W. Determination of ethyl glucuronide and ethyl sulfate from dried blood spots. International journal of legal medicine. Jul 2013;127(4):769-775.
  16. Skipper GE, Thon N, Dupont RL, Baxter L, Wurst FM. Phosphatidylethanol: the potential role in further evaluating low positive urinary ethyl glucuronide and ethyl sulfate results. Alcoholism, clinical and experimental research. Sep 2013;37(9):1582-1586.
  17. Hahn JA, Dobkin LM, Mayanja B, et al. Phosphatidylethanol (PEth) as a biomarker of alcohol consumption in HIV-positive patients in sub-Saharan Africa. Alcoholism, clinical and experimental research. May 2012;36(5):854-862.
  18. Skipper GE, Thon N, DuPont RL, Campbell MD, Weinmann W, Wurst FM. Cellular photo digital breathalyzer for monitoring alcohol use: a pilot study. European addiction research. 2014;20(3):137-142.
  19. Hoiseth G, Bernard JP, Stephanson N, et al. Comparison between the urinary alcohol markers EtG, EtS, and GTOL/5-HIAA in a controlled drinking experiment. Alcohol Alcohol. Mar-Apr 2008;43(2):187-191.
  20. Wojcik MH, Hawthorne JS. Sensitivity of commercial ethyl glucuronide (ETG) testing in screening for alcohol abstinence. Alcohol Alcohol. Jul-Aug 2007;42(4):317-320.
  21. Sarkola T, Dahl H, Eriksson CJ, Helander A. Urinary ethyl glucuronide and 5-hydroxytryptophol levels during repeated ethanol ingestion in healthy human subjects. Alcohol Alcohol. Jul-Aug 2003;38(4):347-351.
  22. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ. Jan 13 1996;312(7023):71-72.
  23. Norwitz ER, Greenberg JA. Promoting evidence-based medicine. Rev Obstet Gynecol. Summer 2008;1(3):93-94.
  24. Shaneyfelt TM, Centor RM. Reassessment of clinical practice guidelines: go gently into that good night. JAMA. Feb 25 2009;301(8):868-869.
  25. Straus SE, Green ML, Bell DS, et al. Evaluating the teaching of evidence based medicine: conceptual framework. BMJ. Oct 30 2004;329(7473):1029-1032.

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Decision Making in Regulatory Medicine: A Framework to Identify the influence of Special Interest Groups and “Bent” Science

mllangan1 9 Comments

content-1In  Bending Science: How Special Interests Corrupt Public Health Research 1  Thomas McGarity and Wendy Wagner describe how special interest groups scheme to advance their own economic or ideological goals by using distorted or “bent” science to influence legal, regulatory and public health policy.

The authors describe a “separatist view” of science and policy that assumes scientific research is sufficiently reliable for public policy deliberations and legal proceedings when it reaches them.  This is illustrated as a pipeline in which it is presumed  the scientific community has properly vetted the information flow through rigorous peer-review and professional oversight.  The final product that exits the pipeline is understood to be unbiased and produced in accordance with the professional norms and procedures of science.   The reliability, integrity and validity of the final product is indubitably accepted.Screen Shot 2015-02-05 at 10.49.27 AMThe separatist  view does not consider the possibility that the scientific work exiting the pipeline could be intentionally shaped and contaminated by biasing influences as it flows through the pipeline.  When this occurs the final product exiting the pipeline is distorted or “bent” and bent science can result in bad decision making and bad policy.

Bent science starts with a pre-determined outcome and works backward from a desired result. It is not true science. Those orchestrating the deception (“benders”) use a variety of tactics and strategies to shape, package and spin science to support their own hidden agenda and suppress opposing science.

Benders attempt to hide, dismiss and debunk contrarian research and unsupportive science.  Benders will attack and harass the science and scientists that pose a threat to their interests. Using carefully crafted studies designed to confirm a desired outcome, the pre-determined conclusions are subsequently promoted and publicized to the relevant stakeholders who are often unable ( or sometimes unwilling) to discern real science from junk-science.

Misinformation, propaganda, and deception are disseminated in a variety of venues. Public relations firms are used to manipulate public perception and freelance writers are hired  brandish favorable consensus statements.  Authoritative reviews and critiques are ghostwritten under the names of  “outside experts” who profit both monetarily and by adding a high-profile publication to their resume.

Opinion is paraded as fact and with a dearth of professional oversight the charade usually goes unnoticed and unopposed.

Data-dredging, cherry picking, confirmatory bias, confirmatory distortion, fabrication, falsification, exaggeration, and a whole host of deceptive tactics are used to work backward from an already determined result.

Any information that contradicts the answer is manipulated, undermined, suppressed or downplayed; even if it is the result of real science and evidence-based research; even if it is the truth.  Professional procedure, protocol and ethics are off the table.  It is an underhanded free-for-all. Bare knuckle boxing. Trash your opponents work and label it junk-science. Undermine the integrity of your opponents.  Use ad hominem attacks to question the opponents motives. Claim the scientists are hacks on the take.  Start rumors about them.Screen Shot 2015-02-05 at 10.50.32 AMLoudly claim you are the one who is evidence based. Proclaim professionalism and authority.  Quibble. Move the goalpost.   Nit-pick and split hairs.  Proclaim over and over and over again you are the one who is evidence based.

And the problem is it usually works.  It is an unfair playing field.  When no meaningful barriers are in place to detect cheating and identify cheaters they usually win.

Bending science can have serious and sometimes horrific consequences and multiple examples including the Tobacco and pharmaceutical industry are given in the book.

Calling for immediate action  to reduce the role that bent science plays in regulatory and judicial decision making, the authors emphasize the assistance of the scientific community is necessary in designing and implementing reform.

“Shedding even a little light on how advocates bend policy -relevant science could go a long way toward remedying these problems.  Indeed, precisely because the advocates have overtaken the law in this area, heightened attention to the social costs of bending science could itself precipitate significant change.”

But there are difficulties in challenging bent science including a general lack of recognition of the problem. With an absence of counter-studies to oppose deliberately manufactured ends-oriented research this would be expected.

Bent science involves the deliberate manufacturing of a pool of  information designed to promote a specific agenda.  A level playing field would require a pool of opposing research specifically addressing that agenda.  In reality this requires both the incentive and the power to do so–an unlikely scenario short of an equally well funded competitor or sufficient public concern about the problem.

In fact counter-forces are often nonexistent. Investigatory techniques developed and promoted by the FBI crime lab (such as firearms identification and intoxication testing) is one example described in the book.  These techniques evolved with little meaningful oversight from the larger scientific community and could be badly bent but there is no meaningful pool of information to disprove them.  The authors aptly state that   “defendants in most criminal cases lack resources to mount effective challenges, much less undertake their own counter-research.”

And part of the “art” of bending involves swaying public opinion and the mainstream media is typically aligned with the benders so opposing viewpoints seldom make the headlines.

Additionally, there is no meaningful oversight or avenue to pursue accountability. No systems exist to prevent, catch and publicly expose bent-science or those who bend science.

The influence of special interest groups on the practice of medicine is unknown.  No one has examined the role of bent science in the rules, regulations, policies and decisions made by those who are in charge of the standards of medical practice and professional behavior of doctors but as a regulated profession governed by the  decisions and policies of regulators it is certainly possible.

Regulation of the Medical Profession

Alexis de Toqueville once observed that a key feature of American government was the decentralized character of administration. “Written laws exist in America,” he wrote, “and one sees the daily execution of them; but although everything moves regularly, the mover can nowhere be discovered. The hand which directs the social machine is invisible.”2

Administrative law is the body of law that allows for the creation of public regulatory agencies and contains all of the statutes, judicial decisions and regulations that govern them. Administrative agencies implement their powers in the form of rules, regulations, orders and decisions.   State medical boards are the regulatory agencies responsible for the licensure and discipline of physicians. They grant the right to practice medicine in the form of a medical license and each state has Medical Practice Act that governs and defines the practice of medicine. The medical board is empowered to take action against a doctor for substandard care, unprofessional behavior and other violations as defined by the state Medical Practice Act.

Administrative Code governs the licensure and disciplinary process and the State Administrative Procedure Act governs the legal process (due process, discovery, etc.). Regulatory changes are enacted through procedural, interpretive and legislative rules.

Both medical practice acts and administrative procedure acts are subject to change.  Changes in medical practice acts can redefine what is acceptable practice and what constitutes professional behavior. This can increase the power and control these agencies have over doctors both professionally and socially.

Changes in Administrative practice acts can decrease what rights a doctor has if this power and control is abused.  Changes in the wording of administrative code and administrative practice acts can have profound implications in these rights including due-process, timeliness of being heard, rights to appeal decisions and time-constraints for judicial review.

And when these changes occur they do so silently.  The hand that directs the machine is indeed invisible.  The consequences, however, are not.  These changes not only impact those touched by the hand but can have a systemic impact on the entire profession.

State medical practice acts as well as administrative practice acts and code are susceptible to change and therefore susceptible to the influence of special interest groups benefitting from such change.  Regulation of the medical profession is thus susceptible to bent science.

Bent Science and the Medical Profession

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The impact of bent science on the regulation of the medical profession has not been studied. As a profession governed by regulatory agencies medicine is certainly not immune to the influence of special interest groups who could in turn influence public policy and regulatory decisions, rules and regulations to benefit their own interests.

Making sound decisions about regulation calls for an understanding of the problem it is intended to solve. This demands methodologically sound science and evidence-based facts arrived at through rigorous peer review and professional oversight. The science on which policy decisions are made must be reliable and unbiased. Legitimate policy must be based on recognized and legitimate institutions and experts.

If the information regulatory agencies rely on to discipline doctors and protect the public is unreliable then serious consequences can occur.

It would be beneficial to look for changes in public policy, guidelines, rules and regulations involving the medical profession and examine the reasons behind them. When did the problem present? Who presented it? Was it based on methodologically sound and accurate data?  What organizations do the problem presenters represent?  What organizations or individuals aligned or associated with the presenters might benefit?  What are the consequences?  Who is harmed?

Howard Becker describes the role of “moral entrepreneurs,” who crusade for making and enforcing rules that benefit their own interests by bringing them to the attention of the public and those in positions of power and authority under the guise of righting a society evil.8   

The mechanics and mentality is similar to the science benders and, as discussed below,  they use some of the same techniques.

Moral entrepreneurs take the lead in labeling a particular behavior deviant and spreading this label throughout society.  They associate the behavior of some group with a society evil, affix an easily recognizable label to it and then express the conviction that the evil must be combated.  Labeled as being outside the central core values of consensual society, the deviants in the designated group are perceived as posing a threat to both the values of society and society itself.

Activities can rise to the level of ‘social problems” when harm or danger is attributed to those activities and governmental powers are called upon to put an end to those harms. Bent science requires convincing others of a viewpoint and the likelihood of this occurring increases when the activity that is identified as a problem resonates with underlying societal concerns and anxieties.  The problem is then endorsed by experts who give legitimacy to such claims.3,4 This legitimacy results attracts media attention which further enforces support from both the public and policy makers.5,6  

As a result any bent science directed at regulatory and public policy decision making should be clearly visible.

The sociologist Stanley Cohen used the term ”moral panic” to characterize the amplification of deviance by the media, the public, and agents of social control.7 According to cultural theorist Stuart Hall, the media obtain their information from the primary definers of social reality in authoritative positions and amplify the perceived threat to the existing social order. The authorities then act to eliminate the threat.9 The dominant ideas or ideologies are reproduced by relying on the opinions of the defining authority and then spread through the media.

An internet search of what labels have been affixed to doctors in association with a threat to society there are three.  A google search of “impaired physician” yields 20, 600 results; “disruptive physician” yields 17, 400 results; and “aging physician” yields 27, 800 results. A large number of these articles, opinion pieces and reviews associate impaired, disruptive and aging physicians with patient death and other adverse events, medical error, and malpractice.   The labels affixed to these physicians have been characterized as a major threat to public health and the rhetorical tools used in many of these articles seems aimed at increasing public anxiety.

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A PubMed search yields 154 results for the “impaired physician”; 47 results for the “disruptive physician”; and 19 results for the “aging physician.”  Many of these are opinion pieces written by the same group of physicians and aimed at hospital administrators, regulators and those involved in the legal or business aspects of medicine.

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There is, in fact, no evidence based research that associates the impaired, disruptive or aging physician with any adverse events. The “impaired,” “disruptive” and “aging” physician labels  as evinced by a quick google search seem escalated far beyond the level warranted by the existing evidence.

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The “impaired” and “disruptive” labels have taken on the status of moral panic and the “aging” label, which is being associated with cognitive impairment, seems to be heading in that direction. The number of articles being published and lectures being given on the dangers of cognitively impaired doctors is increasing.  It has not yet reached the level of public awareness the impaired and disruptive have.

To acknowledge that the current level of concern about these labels is exaggerated is not to suggest they do not exist. They do.  But the disparity between the evidence-base, or lack thereof, and the level of concern warrants further investigation.

To be clear,  doctors who are impaired by drug and alcohol abuse need to be removed from practice to protect the public and receive treatment;  doctors who are abusive to others or engage in behavior that threatens patient care need to be held accountable for their actions; and doctors who are cognitively impaired due to dementia need to be removed from practice and evaluated by the proper specialists.  If a diagnosis of dementia is confirmed then they need to be removed from practice.

What is the motivation behind the “impaired,” “disruptive” and “aging” physician labels and the multiple articles linking these labels to patient harm and medical error?  There is no data driven evidence so where does it come from?   Could moral entrepreneurs be behind it?  If so then there should be evidence  of bent science and to examine this we must look for evidence that these labels have been used to influence regulatory decisions, rules, regulations and policy.

And with the recently archived Journal of Medical Regulation this task can be easily accomplished.

The Journal of Medical Regulation as Timeline and Framework for Policy Evaluation

The Federation of State Medical Boards (FSMB) is a national not-for profit organization that gives guidance to state medical boards through public policy development and recommendations on issues pertinent to medical regulation. Shortly after its founding in 1912, the Federation of State Medical Boards began publishing a quarterly journal addressing issues relating to medical licensing and regulation of doctors. First published in 1913 as the Quarterly of the Federation of State Boards of the United States, the publication has undergone several name changes and publication schedules. From1921 to 1999 it was published monthly as the Federation Bulletin. In 1999 it was changed to the quarterly Journal of Medical Licensure and Discipline and in 2010 was revised to the Journal of Medical Regulation The Journal of Medical Regulation is in the process of archiving all issues dating back to 1913.

Presently every paper dating back to 1967 is available online and the archival organization and availability of full articles published sequentially over the past half-century is historically invaluable.   As the official journal of the national organization involved in the medical licensing and regulation of doctors, this archival organization allows for an unskewed and impartial examination in both historical and cultural context. We can identify when particular issues and problems were presented, who presented them and how.

The Journal of Medical Regulation archives provides a structured context to examine these issues in their historical and cultural context.  This facilitates a retrospective analysis.  As a timeline it allows identification of when the issues were presented.  It also allows us to look at the events preceding the problem, who benefited from them, and the consequences. Could these factors be involved in influencing the regulation of medicine and shaping the medical profession? Could bent science have been involved in regulatory and administrative changes that have significantly impacted the rights and well-being of doctors and how the profession of medicine is defined?  Could some of the current problems such as the marked increase in physician suicide, sham-peer review, and physician burnout be the result of bent science?  If bent science is contributing to bad policy and bad decision making then it need to be exposed and addressed.  Bent science is bad medicine and if it exists then we need to urgently shine a light on it.

  1. McGarity TO, Wagner WE. Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press; 2008.
  2. de Toqueville A. Democracy in America. New York: Penguin Books; 1984.
  3. Blumer H. Social Problems as Collective Behavior. Social Problems. 1971;18:298-306.
  4. Stone DA. Causal Stories and the formation of policy agendas. Political Science Quarterly. 1989;104:280-300.
  5. Best J. Threatened Children, Rhetoric and Concern about Child Victims. Chicago University of Chicago Press; 1990.
  1. Gerbner G, Gross L. The scarey World of TV’s heavy viewer. Psychology Today. 1976;9(89):41-45.
  2. Cohen S. Folk Devils and Moral Panics: The Creation of the Mods and Rockers (New Edition). Oxford, U.K.: Martin Robertson; 1980.
  3. Becker H. Outsiders: Studies in the Sociology of Deviance. New York: Free Press; 1963.
  4. Hall SC, Critcher C, Jefferson T, Clark J, Roberts B. Policing the Crisis: Mugging, the State, and Law and Order. London: Macmillan; 1978.

 

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Making the Data fit the Hypothesis is not Science: The American Society of Addiction Medicine (ASAM), “Weasel Phrases,” “Framing” and “Data-Dredging.”

mllangan1 6 Comments

Screen Shot 2014-12-30 at 1.12.01 AMPrinciples of Addiction Medicine devotes a chapter to Physician Health Programs. Written by Paul Earley, M.D., FASAM,1 Earley states that the lifetime prevalence of substance abuse or addiction in physicians found by Hughes2 is “somewhat less than the percentage in the general population reported by Kessler” of 14.6%.3

Although he specifies the numerical percentage “in physicians at 7.9%,”3 he avoids the use of numbers (14.6%) in the general population. He instead uses the qualifier “somewhat less.” Why is this?

My guess is because it understates the statistical fact that the prevalence found by Kessler in the general population was almost twice that found by Hughes in physicians.

You see, “Somewhat less” is a “detensifier.” It creates an impression of a small disparity between doctors and the general population.

In propaganda this is what is known as a “weasel phrase.”   Weasel phrases are used to obfuscate the truth.   Weasel phrases mislead those either without the time, or without the sense to see or look any deeper. The problem is it works.

“Methodologic differences may account for this difference,” Earley states, as the Hughes study “surveyed 9, 600 physicians by mail” and “relied on honest and denial-free reports by the physicians; the Kessler study utilized face-to-face interviews with trained interviewers.”1

This is an example of language framing. Language framing uses words and phrases to direct attention to a point of view to advance a vested interest.

In this case the use of the phrase “honest and denial free” in the context of physician reporting imparts associative meaning to the reader.

As denial is a recurring motif and cardinal attribute of physician addiction according to the paradigm, the connotation is that the reports by physicians may have been influenced by dishonesty and denial while face-to-face interviews done by “trained” interviewers were not.

“Framing” is another propaganda technique designed to tell the audience how to interpret the information given through context.   The message here is that the somewhat less lifetime prevalence of substance abuse and addiction in physicians found by anonymous mail survey may be underreported as a result of both methodology and denial.

But in actual fact there is a large body of research regarding “social desirability bias” that shows the converse to be true.

One of the most consistent findings of studies of this kind is that socially desirable responding is significantly more likely with face-to-face administered data collection compared with self-administered anonymous modes.4-6

Tourangeau et al. reviewed seven studies comparing self-reports of drug use in surveys conducted in different modes. For each estimate obtained in the studies they calculated the ratio of drug use reported in self-reported surveys to the corresponding estimates in interviewer administered surveys and found that 57 of 63 different comparisons showed higher levels of reporting of drug use in the self-reported mode.7

The principal cause of social desirability bias is the level of perceived anonymity of the reporting situation.7

Evidence-based research does not support Earley’s claim that methodological differences in study design explain the difference in reported lifetime prevalence of substance abuse or addiction between physicians and the general population in these two studies.

Evidence based research would, in fact, make the findings more robust.

Moreover, I find it hard to comprehend the psychodynamics, motivation, and logic of denial and dishonesty in influencing an anonymous survey. So too would anyone else who dare peer beneath the veil. It is, in fact, a Potemkin village. In reality the emperor has no clothes.

  1. Earley PE. Physician Health Programs and Addiction among Physicians. In: Ries R, Fiellin D, Miller S, Saitz R, eds. Principles of Addiction Medicine. 4 ed. Baltimore: Lippincott Williams & Wilkens; 2009:531-547.
  2. Hughes PH, Brandenburg N, Baldwin DC, Jr., et al. Prevalence of substance use among US physicians. JAMA : the journal of the American Medical Association. May 6 1992;267(17):2333-2339.
  3. Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Archives of general psychiatry. Jun 2005;62(6):593-602.
  4. Sudman S, Bradburn NM. Response effects in surveys: A review and synthesis. Chicago: Aldine Publishing; 1974.
  5. Tourangeau R, Smith TW. Collecting sensitive information with different modes of data collection. In: Couper MP, Baker RP, Bethlehem J, et al., eds. Computer assisted survey information collection. New York: John Wiley & Sons, Inc.; 1998.
  6. Dillman DA. Mail and telephone surveys: The total design method. New York: Wiley-Interscience; 1978.
  7. Tourangeau R, Rips LJ, Rasinski KA. The Psychology of Survey Response. Cambridge: Cambridge University Press; 2000.
  8. American Society of Addiction Medicine: Patient Placement Criteria. Chevy Chase, MD: American Society of Addiction Medicine; 2000.
  9. Merlo LJ, Gold MS. Successful Treatment of Physicians With Addictions: Addiction Impairs More Physicians Than Any Other Disease. Psychiatric Times. 2009;26(9):1-8.

Oliver Wendell Holmes, the Massachusetts Medical Society, Tinsel Erudition and Pretended Science Redux

mllangan1 2 Comments
images-10As the oldest medical society in the United States the Massachusetts Medical Society can count some of the greatest minds in the history of American medicine as members.  My how far we have fallen.  This same author has previously unintelligibly compared the field of medicine to Barbra Streisand’s face and shamelessly and opportunistically blamed the Boston Marathon bombing on “marijuana withdrawal.” 
 
The sophomoric mnemonics are neither clever nor illuminating.  Unworthy of  Readers Digest circa 1957, this dumbing down of doctors needs to end.  The very soul and practice of medicine is being castrated and lobotomized by the same dull and very very blunt instrument. 
How does one reconcile the fact that the very same medical society that publishes the New England Journal of Medicine is allowing this type of tripe and rabble to get past editorial review?  In 1969, through an act of the state legislature, the Massachusetts Medical Society updated its mission to read:

“The purposes of the Massachusetts Medical Society shall be to do all things as may be necessary and appropriate to advance medical knowledge, to develop and maintain the highest professional and ethical standards of medical practice and health care, and to promote medical institutions formed on liberal principles for the health, benefit and welfare of citizens of the commonwealth.”

With a foundation and history built and based on of scholarship and critical thought we need to support the highest levels of science, fact, intelligence and reason.  Stupidity tries but it should not rein.    Before the Boston Society for the Diffusion of Useful Knowledge in 1842, Dr. Oliver Wendell Holmes delivered two long lectures entitled “Homeopathy and Its Kindred Delusions.” He characterized one of its popular practitioners, Dr. Robert Wesselhoeft, as one of those:  

“Emperics [quacks], ignorant barbers, and men of that sort…who announce themselves ready to relinquish all the accumulated treasure of our art, to trifle with life upon the strength of these fantastic theories.” That “pretended science” as Holmes called it, was “a mingled mass of perverse ingenuity, of tinsel erudition, of imbecile credulity, and artful misrepresentation, too often mingled in practice…with heartless and shameless imposition.”

And Holmes words are as apt and appropriate today as they were in mid 19th Century Boston!   Probably more so.

History has recurrently proved that false constructs and groundless concepts allow for endless error.

The Massachusetts Medical Society needs to come to the realization that Physician Health Services is engaging in procedural, ethical and legal breaches.  
The evidence is clear that past medical director Dr. Luis Sanchez and Director of operations Linda Bresnahan are engaging in not only unethical but criminal activity within the walls of the MMS.  Egregious misconduct including forensic fraud and political abuse of psychiatry can be seen in detail here, here and here.
This is not a matter  of opinion but a matter of fact.  It has been ascertained by outside agencies and can also be confirmed by two former associate directors at PHS.    What more does the MMS need?   This type of misconduct can have grave and far reaching consequences for referred doctors and needs to be addressed urgently with precise, firm methods.   To ignore the problem or suggest that it does not exist will only cause more damage.
The majority of Massachusetts Medical Society members are honest, thoughtful and responsible.   Most are unaware of the ethical and criminal allegations concerning PHS..  It is time they become aware as sunshine is the best disinfectant.   As the most crucial step in solving a problem is admitting it exists I am requesting this be ascertained or refuted based on the documents and examined procedurally, ethically and legally. If there is no problem then the MMS should have no problem supporting or justifying the actions of Dr. Luis Sanchez, Dr. Wayne Gavryck and Linda Bresnahan. If the MMS cannot justify, support or defend these actions then it must be concluded that these individuals have violated professional protocol,,  professional and community ethics and the law. And if that is the case it is the responsibility of the MMS to admit the problem exists, define it and address it.  It is the responsibility of the MMS to facilitate exposure and that those engaged in wrongdoing be held appropriately accountable for their actions.  I am sure no one at the MMS would disagree that forensic fraud be met with Zero-tolerance.    The criminal and ethical violations shown here do not comport with any codes of conduct including those of the medical society.   Those engaging in forensic fraud must be removed.
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Good leadership requires correct moral and ethical behavior of both the individual and the organization. .  Integrity is necessary for establishing relationships of trust.  It requires a true heart and an honest soul.  People of integrity instinctively do the “right thing” in any and all circumstances.  Adherence to ethical codes of the profession is a universal obligation.  It excludes all exceptions.  Without ethical integrity, falsity will flourish.

The documentary evidence here shows fraud. It is intentional.  All parties involved knew what they were doing, knew it was wrong but did it anyway.  The schism between pious rhetoric and reality is wide.

One measure of integrity is truthfulness to words and deeds.  These people claim professionalism, ethics and integrity.  The documents show a reality of hypocrisy and sanctimony.   But the hypocrisy seen here is also a danger because the careers and lives of doctors in Massachusetts are in these peoples hands.

-Michael Langan, M..D.
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Disrupted Physician

images-10As the oldest medical society in the United States the Massachusetts Medical Society can count some of the greatest minds in the history of American medicine as members.  My how far we have fallen.  This same author has previously unintelligibly compared the field of medicine to Barbra Streisand’s face and shamelessly and opportunistically blamed the Boston Marathon bombing on “marijuana withdrawal.”
 
The sophomoric mnemonics are neither clever nor illuminating.  Unworthy of  Readers Digest circa 1957, this dumbing down of doctors needs to end.  The very soul and practice  of medicine is being castrated and lobotomized by the same dull and very very blunt instrument. 
How does one reconcile the fact that the very same medical society that publishes the New England Journal of Medicine is allowing this type of tripe and rabble to get past editorial review?  In 1969, through an act of the state legislature, the Massachusetts Medical…

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Junk-Science in the Medical Profession: The Resurgence of Polygraph “Lie-Detection” in an age of Evidence-Based Medicine

mllangan1 7 Comments

Junk-Science in the Medical Profession: The Resurgence of Polygraph “Lie-Detection” in an age of Evidence-Based Medicine.

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Circa 1995

The article below was published in the now defunct magazine Gray Areas almost twenty years ago. (Vol. 4, No. 1, Spring 1995 pp. 75-77).   Antipolygraph.og founder George Maschke noted in 2008 that article “makes a good introduction to the pseudoscience of polygraphy” and “the criticisms of polygraphy remain valid today.”  They still do.

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The Art of Deception: Polygraph Lie Detection

By Michael Lawrence Langan, M.D.

I’d swear to it on my very soul, If I lie, may I fall down cold.”

– Rubin and Cherise
(Hunter/Garcia)

The accuracy of polygraphic lie detection is slightly above chance. Nevertheless, State and local police departments and law enforcement agencies across the United States are devoted proponents of this unscientific and specious device. In addition, the American public seems to lend an implicit credence to the “lie detector” as evinced by its ubiquitous use on television crime shows and in “whodunit” literature. It is given overt attributions of credibility on tabloid type talk shows and news shows. For example, in the highly publicized case of Tonya Harding a reporter stated, not with removed objectivity but with sardonic grin and mocking emphasis, that the accused had failed two polygraph tests. The implied assumption is that if the person has failed the polygraph test, then therefore he or she is guilty regardless of other evidence. Bottom line. Culpa ex machina. End of story.

Lie detection by the polygraph is based on the premise that the act of telling a lie causes specific, universal, and reproducible physiological responses as manifested by the autonomic nervous system. (Saxe, 1991) These physiological responses, which are largely outside the influence of voluntary control, are then measured by the polygraph instrument. The polygraph itself is simplistic in design. It consists of several devices which are attached to the subject to record blood pressure, pulse, respiration, and galvanic skin response (which is related to perspiration). The results are then recorded on a moving paper by a “kymograph.” Hence any change of one of the autonomic nervous system variables will be recorded on the paper as a change from baseline. The polygraph examiner then interprets the tracing. A characteristic change from baseline on a relevant question is interpreted as a lie.

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In fact, the polygraph test does measure autonomic nervous system activity. The role of the autonomic nervous system with its sympathetic and parasympathetic branches is well defined within the field of medicine, and was well described by the French physician Claude Bernard over a century ago. The primary role of the autonomic nervous system is to maintain bodily homeostasis to allow the individual to exist in a changing environment.

Simplistically described, the autonomic nervous system is a part of the peripheral nervous system which consists of a variety of outgoing nerve pathways that regulate important physiological functions generally outside of voluntary and conscious control. Thus, respiration, body temperature, heart rate, digestion, sweating, and blood pressure are all, partly or entirely, regulated by the autonomic nervous system. It is divided into sympathetic and parasympathetic branches which have contrasting functions in terms of effect. The sympathetic branch increases heart rate, respiratory rate, blood pressure, and perspiration. It is active at all times but varies with the constantly changing environment, and is especially active during rage or fright and prepares the body for the so called “fight or flight” phenomenon. Many of these reactions are caused by the release of epinephrine. The parasympathetic nervous system, on the other hand, is primarily involved with conservation and restoration. It is the sympathetic branch of the autonomic nervous system that the polygraph measures in terms of its activity. Thus, from a medical perspective it is entirely valid that the polygraph will accurately measure sympathetic nervous system activity with its instrumentation.

The false assumption of the polygraph test is that dishonesty is the sole cause of sympathetic arousal during a polygraph examination. Deception is a cognitive phenomenon that cannot be measured. Indeed, throughout the entire history of medicine there has not been a single scientific study that demonstrated evidence that a cognitive phenomenon (such as love, hatred, truth, altruism, jealousy) could be measured. Since, in the complex realm of truth and deception, there is no known physiological response that correlates with lying, then there is no validity to the test. Although the act of lying can elicit fear and anxiety via the sympathetic nervous system, so can multiple other confounding and complex emotional factors including stress, embarrassment, anger, and fear. “Deception itself cannot be measured directly.” (Steinbrook, 1992) In addition, each individual differs in autonomic lability. Some people stay calm with a gun at their head. While others get autonomically excited, with heart thumping and palms sweating at simply shaking someone’s hand.

In reality, the examination itself is inherently designed to elicit fear and anxiety. It is an interrogation. If this fear and anxiety are recorded on a relevant question, then you have failed that question according to the polygraph “experts.”

The polygraph technique begins with a pre-test. After a sixth-grade level lecture on the nervous system and a proclamation of the test’s infallibility, the examiner will go over all of the questions that have been formulated.

These questions consist of control questions, relevant questions, and irrelevant questions. The subject will then be attached to the polygraph equipment and the formal testing begins.

The most crucial questions on the polygraph examination, or “Control Question Test,” are the control questions and relevant questions. The control questions are garnered from the suspect by asking him an innocuous question which could not be truthfully denied. For example, “Have you ever thought of hurting someone?” or “Have you ever lied to anyone?” The responses to the control questions will elicit some degree of autonomic activity which can then serve as a baseline for which to compare subsequent questions. The relevant questions pertain to the actual investigation at hand. The magnitude of responses to relevant questions and control questions as compared with the irrelevant questions is then interpreted, in a non-blinded manner, by the examiner. The assumption is, that if you are prevaricating, the relevant questions will cause a greater response than the control questions. So if the question “Have you ever been late for an appointment?” (control question) elicits less of an emotive response on the polygraph equipment than “Did you murder and rape your girlfriend?” (relevant question) you have failed the test. And, according to the American Polygraph Association (APA) you are lying. Assuming the subject is innocent, it is fairly obvious that he would respond with more emotional autonomic activity to a question regarding a recently deceased loved one than he would an inquiry about punctuality. Obvious to everyone, that is, but the APA.

The APA is a professional organization for polygraph examiners who have complete faith in the accuracy of the test. They have their own trade journalPolygraph in which they report scientifically worthless studies and brandish anecdotes of the wonders of their trade. The majority of these members can pride themselves on completing a 6 week to 6 month post- high school training course in the art of polygraphy. They have no formal training in medicine, psychology, physiology, or behavior; the very disciplines on which the testing is based. The majority of them cater to the legal system wherein their economic livelihood depends.

Since they are primarily paid to identify guilty suspects, motivational factors may play a part in their eagerness to find the guilty suspect. (Kleinmuntz, 1987)

The accuracy of any test is determined by that test’s sensitivity (ability to find a positive) and specificity (ability to find a negative). A polygraph examiner will ardently tell you that the exam has somewhere in the neighborhood of a 95% sensitivity rate. This means that if 100 guilty suspects are given a polygraph exam, 95 of them will be detected through the test. Only five of the 100 will be a false negative and not be detected by this miraculous method. Likewise they will claim a similar specificity rate, and state that if you are telling the truth then you have almost a 100% chance of being cleared by the test. John Reid, the inventor of the Control Question Test claimed 99% accuracy. (Reid and Inbau, 1977)

This is clearly not accurate. The polygraph was not subjected to much critical and scientific investigation until the last two decades. (Saxe, et al., 1983) Since this time there have been a number of studies of sound scientific design and methodology which clearly refute the high specificity and sensitivity that polygraph advocates claim. These studies have appeared in reputable peer-reviewed journals and not trade publications. Horvath, for example, reported a sensitivity of 76 percent and a specificity of 52 percent. (Horvath, 1977) This means that out of 100 liars 76 of them will be detected by the polygraph. What is astonishing though is the specificity of 52 percent. This means that out of 100 people who are not lying, 52 will be identified as telling the truth while 48 of the honest individuals will be branded as liars. The odds are similar to that of a coin toss which would have a specificity of 50 percent. Barland and Raskin’s study actually demonstrated a specificity of 45%. Worse than a coin toss. (Barland and Raskin, 1976) Multiple other studies have shown similar results. (Brett, et al., 1986, Kleinmuntz and Szucko, 1984, Lykken, 1984).

The polygraph examiner likens his “skill” to that of the radiologist reading a chest X-Ray or a cardiologist interpreting an EKG. (Barefoot, 1974) This analogy is not only ridiculous but, in fact, if a medical test had a similar sensitivity and specificity to that of the polygraph examination it would simply not be used in the field of medicine. They will cite the fact that the polygraph has been used in the United States for greater than 70 years as if longevity is directly related to validity. They will state that they have personally administered hundreds or thousands of these tests, and have almost never been wrong, as if total number of tests given constitutes accuracy.

They are so convinced of the accuracy of the polygraph that they regard opponents of polygraphy as communists and do-nothing professors. (Arther, 1986) It doesn’t occur to them that someone with a Ph.D. and years of research experience, in the very subjects they ignorantly dabble in, may know something more than they do.

It is astounding that the criminal justice system has institutionalized and perpetuated a so called “technology” that lacks scientific evidence and is in fact rejected by the scientific community. It is as ludicrous as procuring the so called “love meter” machine from the amusement park which measures galvanic skin response and placing it in the courtroom. But in a backward legal system which has been known to use psychics to help with unsolved murders and has allowed the mentally retarded to serve as jurors, it is not entirely surprising.

The tool is useful to them, however, in that 25 to 50 percent of examinees will, under the tense psychological pressure of the exam, confess to the misdeed at hand. (Lykken, 1981, Lykken, 1991) Persuaded that they have been proven dishonest by “scientific” means they give up hope. It is usual for the polygraph examiner to interrogate the subject who has failed the test. They will state that there is no way now to deny the objective guilt demonstrated by this impartial and unbiased scientific device, and that the only available option is to confess.

The assessment by the polygrapher is genuinely convincing because, sadly, he believes it himself. Thus the instrument is clearly useful as a confession inducing device. One wonders, over the past 70 years, how many false confessions have been obtained in this way from innocent persons.

In summary, the polygraph is a ludicrous implementation of pseudo-science at its worst. The members of the APA are non-scientists practicing science, and the consequences are often dire. Lykken reports the cases of three men who were convicted of murder largely due to the polygraph examiner’s testimony that in their “expert opinion” they had failed the test. All three were subsequently found to be innocent. (Lykken, 1991) Polygraph examiners ignore such cases or rationalize that they are due to the rare incompetence of some examiners.

The continued use of polygraphic lie detection has the potential to cause much harm to those who are judged dishonest by its results. The specificity and sensitivity are not dissimilar to that of a coin toss. Innocent suspects have about a 50/50 chance. One failure is all it takes to ruin your life. Since the 1923 Federal Court decision of Frye vs United States (293 F 1013 [DC Cir 1923]), polygraph evidence has not been admissible in federal court cases because there was deemed a lack of scientific validity to the test. This travesty however is still used widely by the state court system. Furedy characterizes the continued use of polygraphy as a serious “social disease.” (Furedy, 1987) State laws regarding abuse of the polygraph must change, and it is time for the medical and scientific communities to educate lawmakers and policy makers about the true validity of this perversion of science. It must be forever banished to the same realm of parapsychology as the Ouija Board, phrenology, and palmistry. The relatively conservative American Medical Association’s Council on Scientific Affairs recommended that the polygraph not be used in pre-employment screening and security clearance. (Council on Scientific Affairs, 1986) It is time to extend this recommendation across the board, and put the greater than 3000 anachronistic polygraph examiners in the United States out of business.

Meanwhile, if you are asked to take a polygraph test–don’t do it. Those involved in the criminal justice system, including lawyers, are largely uneducated in the realm of scientific scrutiny and experimental methodology.

They may not separate science and pseudo-science, and erroneously believe that the polygraph is an accurate scientific instrument. Their interactions are with polygraph examiners who proselytize its use, and they have little or no interaction with scientists, psychologists, and physicians who refute its use. Refuse to take the test and educate them. Cite the Frye doctrine, go to the medical library, copy the scientific articles which belie its validity, and present them to whomever requested you to take the test. State that the principles and assumptions underlying polygraphy are not supported by our understanding of psychology, neurology, and physiology. Then put the burden of proof on their heads. Tell them to present you with scientific evidence that corroborates the validity of the test. There is simply no rational basis for a machine to detect liars.

References

Arther RO. 1986. The polygraph’s enemies: An update. Journal of Polygraph Science. 20: 133-136.

Barefoot J. 1974. The Polygraph Story. Cluett Peabody and Co., New York.

Barland, G, Raskin D. 1976. Validity and reliability of polygraph examinations of criminal suspects (Report 76-1, Contract 75 NI-99-0001).

Brett AS, Phillips M, Beary JF. 1986. Predictive power of the polygraph: Can the “lie detector” really detect liars? The Lancet. 1: 544-547.

Council on Scientific Affairs. 1986. Polygraph. Journal of the American Medical Association. 256: 1172-1175.

Furedy JJ. 1987. Evaluating polygraphy from a psychophysiological perspective: a specific-effects analysis. Pavlovian Journal of Biological Sciences.22: 145-151.

Horvath F. 1977. The effect of selected variables on interpretation of polygraph records. Journal of Applied Psychology. 62: 127-136.

Kleinmuntz B. 1987. The predictive power of the polygraph: The lies lie detectors tell. Journal of the American Medical Association. 257: 189-190.

Kleinmuntz B, Szucko J. 1984. A field study of the fallibility of polygraphic lie detection. Nature. 308: 449-450.

Lykken D. 1984. Polygraph Interrogation. Nature. 307: 681-684.

Lykken DT. 1981. A tremor in the blood: Uses and abuses of the lie detector. McGraw-Hill, New York.

Lykken DT. 1991. Why (some) Americans believe in the lie detector while others believe in the guilty knowledge test. Integrative Physiological and Behavioral Science. 26: 214-222.

Reid JE, Inbau FE. 1977. Truth and deception: The polygraph (“lie detector”) technique. Williams & Wilkins, Baltimore.

Saxe L. 1991. Science and the CQT polygraph: A theoretical critique. Integrative Physiological and Behavioral Science. 26: 223-231.

Saxe L, Dougherty D, Crosse T. 1983. Scientific validity of polygraph testing: a research review and evaluation. Conference: OTA-TM. U.S. Congress Office of Technology Assessment.

Steinbrook R. 1992. The polygraph test – A flawed diagnostic method. The New England Journal of Medicine. 327: 122-123.

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Transcription and HTML by AntiPolygraph.org

Published in Gray Areas, Vol. 4, No. 1 (spring 1995), pp. 75-77. This article may also be downloaded as a 1 mb scanned PDF file.https://antipolygraph.org/articles/article-053.pdf

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Press Release | Forensic Science Misconduct: A Dark and Cautionary Tale | @csidds

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Press Release | Forensic Science Misconduct: A Dark and Cautionary Tale | @csidds.

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Originally posted on FORENSICS in FOCUS @ CSIDDS | News and Trends:

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Don’t expect a “whodunnit” version of CSI victories in this Op-ed blog article about a darker side of the forensic sciences. It is from an author with ample forensic credentials and experience from both within and outside criminal courts of the US. The article has topics ranging from the continued use of outdated or grossly over hyped “CSI” methods, ethical and moral failures in some forensic groups, to the criminal courts inability to understand much of anything about what is “real ” versus self-serving personal opinion called “science.” A measure of proof confirming these systemic problems is the article’s presenting a glimpse into the multi-million dollar costs to taxpayers for damages won by those wrongfully convicted with the help of court-qualified forensic testimony. Some optimism about better scientific scrutiny is presented but the institutional inertia resisting legitimate change in some forensic organizations, government agencies, and criminal  justice institutions is still…

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EtG–The Rosie Ruiz of Bent Science and Bad Medicine

mllangan1 27 Comments

The Displacement of the idea that facts and evidence matter, by the idea that everything boils down to subjective interests and perspectives is — second only to American political campaigns — the most prominent and pernicious manifestation of anti-intellectualism in our time. — Larry Laudan, Science and Relativism (1990)Screen Shot 2015-03-19 at 11.55.08 PMOn April 21, 1980 Rosie Ruiz appeared to win the 84th Boston Marathon’s female category with a time of 2:31:56.  Her time would have been the fastest female time in Boston Marathon history and and the third-fastest female time ever recorded in any marathon.

“Miss Ruiz, an administrative assistant for Metal Trading Inc. in Manhattan, received the traditional laurel wreath, a medal and a silver bowl for her victory,” According to the New York Times

Ruiz was unknown in the running world and her victory raised suspicions.  After studying marathon photographs she didn’t appear in any of them until the very end and conducting interviews.

The problem was that, according to Runners World: “Ruiz had dropped out of the race, hopped on the subway, got off about a mile from the finish line, and ran in from there.”   It is believed Ruiz intended to jump in in the middle of the pack but miscalculated when she joined so close to the end not realizing she was ahead of the other 448 female runners.Screen-Shot-2014-12-29-at-10.16.38-AM

Marathon officials stripped Ruiz of her title on April 29, 1980, and named Jacqueline Gareau of Canada the women’s division champion with a time of 2:34:28.  It was later discovered that she had also taken the subway during part of the New York City Marathon which qualified her for the Boston Marathon.  In 1982 she was caught stealing money from her employer and was subsequently caught selling drugs to an undercover officer in Florida.

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In the early 1950’s it was discovered that a small fraction of ingested alcohol in rabbits gets metabolized by conjugation with glucuronic acid to form Ethyl Glucuronide (EtG)..1,2 The potential of EtG as a marker for alcohol consumption was recognized in the 1990s and analytical methods for its determination were developed in urine, blood and hair.3-5

It’s use as a marker of alcohol consumption in forensic settings was subsequently suggested by Dr. Friedrich Wurst based on studies showing that urine EtG could be detected after complete elimination of alcohol from the body (up to 80 hours), and he suggested the alcohol biomarker be utilized in forensic monitoring to improve public health.   6,7

Wurst et al note that a “marker of high sensitivity and specificity capable of monitoring patients in treatment for alcohol or other drug abuse” could “improve therapy outcome and quality of life in patients, increase safety at work places and in traffic, avoid harm to the unborn during pregnancy (fetal alcohol syndrome) and reduce costs by making therapy more effective and reducing productivity loss.”7

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A literature search from 1952 to 2002 yields one conclusion and once conclusion only; EtG measurements increase with alcohol ingestion. There are no studies considering what other factors might increase EtG measurements.

The false logic takes the following form:

  • Premise: Event A occurred after (or with) event B.
  • Conclusion: Therefore, event A caused event B.

But in 2003 Wurst and Gregory Skipper, M.D., FASAM, Medical Director of the Alabama Physician Health Program reported at an international meeting of the American Medical Society that EtG provided proof of alcohol consumption as much as 5 days after drinking an alcoholic beverage and that there are now a substantial number of studies in the world literature that support the clinical importance and reliability of EtG as a marker of recent alcohol consumption.8

“In the future it will be negligent not to test for EtG when monitoring recovering alcoholics,” reported Dr. Skipper.8

Also, in 2003, Skipper pitched the test to National Medical Services, Inc. (NMS labs) who then developed it as a Laboratory Developed Test (LDT).9

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Because of its high sensitivity the newly marketed test was suggested as a tool to monitor health care professionals by Skipper in 2004.10   Skipper then approached the Federation of State Medical Boards and pitched the test to them proposing it be used in the assessment and monitoring of doctors by state Physician Health Programs.   In a stunning example of policy entrepreneurship a market was created and filled simultaneously.

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“Detection of Alcohol Use in Monitored Aftercare Programs: A National Survey of State Physician Health Programs”11 published in the Journal of Medical Licensure and Discipline in 2004 found that “surreptitious alcohol use was a significant concern” for state Physician Health Programs (PHPs) yet no “best methods for detecting alcohol use.” The 36-question phone interview was conducted with directors of PHPs in 46 states regarding current methods of drug testing and notes:Screen Shot 2015-03-20 at 4.06.32 AM

“Because alcohol is the most frequently abused substance adequate monitoring for alcohol is a major concern. During rehabilitation and recovery, the potential for alcohol abuse may increase due to the lack of efficient screening tests. The ingestion of alcohol while in aftercare is a violation of the contractual agreement made with the monitoring program and may lead to relapse and/or abuse of other psychoactive substances, thus rendering the practitioner unsafe to practice their profession. Therefore, alcohol detection remains an important component of contract compliance and sobriety.”

Screen Shot 2015-03-19 at 9.09.39 PMThey conclude that: “EtG can be detected in urine as long as 18 hours after blood alcohol levels reach zero and demonstrates exceptional specificity (100 percent) and sensitivity because even small amounts of alcohol (7 g, or less than one alcoholic beverage) can be detected.”

This very same issue of the Journal of Medical Licensure and Discipline contains an article written by Skipper concerning new marker to detect alcohol use in “recovering physicians” that “has recently been introduced in the United States and an assay for EtG is now commercially available.”12

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Skipper states that “EtG is not detectable unless alcohol has been consumed” and notes the “usefulness of the test was affirmed in one study involving psychiatric inpatients”Screen Shot 2015-03-19 at 9.09.15 PM

An EtG above 500 renders it “extremely unlikely” that alcohol was not ingested and adds “ In any event, if testing is positive” in monitored doctors it is advisable to refer them for further in-depth evaluation by clinicians or programs skilled and adept at evaluating physicians.”

In Bending Science: How Special Interests Corrupt Public Health Research13, Thomas McGarity and Wendy Wagner describe how special interest groups scheme to advance their own economic or ideological goals by using distorted or “bent” science to influence legal, regulatory and public health policy.

The authors describe a “separatist view” of the world that assumes scientific research is sufficiently reliable for public policy deliberations and legal proceedings once it flows out of the realm of science through a pipeline in which the scientific community has ensured through rigorous peer-review and professional oversight that the final product that exits the pipeline is unbiased and produced in accordance with the norms and procedures of science.

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This view does not consider the possibility that the scientific work exiting the pipeline could be distorted and contaminated by biasing influences.

If we look at this through the lens of “bent science” several issues arise including a failure to adhere to the norms and standards of toxicology and forensic drug and alcohol testing, an absence of evidence base and glaring conflicts of interests.

Norms and Standards of Toxicology and Forensic Drug Testing

On September 15, 1986 President Ronald Reagan signed Executive Order 12,564 requiring that the urine of federal employees in “sensitive” jobs be sampled randomly for illegal drugs. In 1988 Congress followed with the Drug-Free Workplace Act and drug testing became common organizational practice by the mid 1990s. Most followed the federal norms and procedures in their testing.

The Department of Health and Human Services (DHHS) had established specific cutoff levels that define a positive result.   These values were developed to help eliminate false-positive results.14 The cutoff levels were originally established at a drug concentration that produced an analytic signal some multiplicative factor above the noise level (the signal obtained from drug free urine).

“The concept of cutoff for major urine screening programs has two basic applications: the lower limit of reliable testing based on the techniques involved in the testing and the lower limit of reliable testing based on the possibility of interference from medications, foodstuffs, environmental exposure, or endogenous processes.”15

“Urine Drug Testing in Clinical Practice: Dispelling the myths & Designing Strategies cautions about “caveats to interpretation.” “As with any unexplained test result, it is important to clarify the interpretation with someone knowledgeable in clinical toxicology.”16

Evidence Base

What was in the pipeline when the EtG was proposed as a forensic monitoring tool can be illustrated below:

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Taking Advantage of a Loophole

The EtG was developed by NMS labs as a “Laboratory—Developed Test” or LDT. The LDT pathway does not even require proof of validity, that the test is actually testing for what it claims to be testing, and with no FDA oversight a lab can claim any validity it wants in its marketing and sales, and they did.   Proponents for regulation of LDTs argue this lack of oversight is a direct threat to patient care and safety. An viewpoint piece in JAMA states that a   “patient’s life or death could hinge on whether a single, unregulated diagnostic test result is meaningful.” 17

In the case of EtG Skipper arbitrarily chose a value of 100 as a cut-off for EtG. The rationale behind this value is not cited. Interference with foods, medications and environmental exposures had not been worked out. The results were predictable.

Aftermath was Predictable and Therefore Avoidable

The case of EtG is exemplifies ‘policy entrepreneurship” and “bent science” at its worst. It shows how junk-science can be introduced into the market without any real difficulties or meaningful opposition and how self-interest is promoted in defiance of science in an effort to manipulate public policy. This is nothing more than opportunist exploitation of the regulatory framework and the FSMB eagerly complied.   Without this “regulatory sanctification” none of these tests would have ever made it to market.

EtG was subsequently found to be so sensitive that it could measure incidental exposure to alcohol in foods, over the counter cold medications, mouthwash18,19, hand sanitizer gel20, nonalcoholic beer21, and nonalcoholic wine.22

“Exposure to ethanol-containing medications, of which there are many, is another potential source of “false” positives.

Forbidding patients/subjects access to such medications may be unrealistic, and even unwise.”23

The United States Substance Abuse and Mental Health Services Administration warned against using a positive EtG as primary or sole evidence of drinking for disciplinary or legal action.24 The advisory states:

“Although positive biomarker results should be taken seriously, use of certain biomarkers, such as EtG, is now warranted as stand-alone confirmation of relapse because research has not yet established an acceptable standard to distinguish possible exposure to alcohol in various commercial products from consumption of alcoholic beverages.”

The Wall Street Journal in 2006 reported the problems with the EtG to the general public.25

The authors of a 2011 study demonstrating that hand sanitizer alone could result in EtG concentrations of 1998 concluded that:

“in patients being monitored for ethanol use by urinary EtG concentrations, currently accepted EtG cutoffs do not distinguish between ethanol consumption and incidental exposures, particularly when urine specimens are obtained shortly after sustained use of ethanol containing hand sanitizer.”26

images-5Sauerkraut and bananas have even recently been shown to cause positive EtG levels.27

A 2010 study found that consumption of baker’s yeast with sugar and water28 led to the formation of elevated EtG above the standard cutoff.images-6

EtG can originate from post-collection synthesis if bacteria is present in the urine.29 Collection and handling routines can result in false-positive samples.30

EtG varies among individuals.31 Factors that may underlie this variability include gender, age, ethnic group, and genetic polymorphisms.

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The Cochrane Collaboration does systematic reviews of the literature using conscientious, explicit, and judicious criteria to in order to produce and disseminate only high quality and evidenced based health care, exclude bias, and enhance transparency.

The Cochrane database is internationally recognized as the standard in evidence based health care.   It records just 5 controlled trials under the topic ethyl glucuronide.22,31-33

These 5 studies represent the only high-quality evidence regarding EtG to date. Information provided by the five studies suggests the following, and only the following:

  1. EtG measurements increase with alcohol ingestion.
  2. The window of detection is shorter than what is commonly proposed (80 hours).
  3. Individual values are variable both within and between subjects.
  4. Non-alcoholic wine can cause positive levels.

During this time period any rational authority would have admitted error and removed the test from the market. Skipper’s approach was to keep raising the cutoff level from 100 to 250 to 500 to 1000. With EtG paving the way for other laboratory developed tests he then added “confirmatory” LDTs such as EtS and PEth. The EtS was found to have the same problems and PEth inevitably will but this is now a billion dollar market and they plan on using these tests on almost everyone including kids.

There has been no academic, public policy or conflict of interest analysis of all of this. As probably the worst case of bent-science in history there needs to be.

  1. Kamil A, Smith JN, Williams RT. A New Aspect of Ethanol Metabolism: Isolation of ethylglucuronide. Biochemical Journal. 1952;51:32-33.
  2. Kamil IA, Smith JN, Williams RT. Studies in detoxication. L. The isolation of methyl and ethyl glucuronides from the urine of rabbits receiving methanol and ethanol. The Biochemical journal. Jun 1953;54(3):390-392.
  3. Schmitt G, Aderjan R, Keller T, Wu M. Ethyl glucuronide: an unusual ethanol metabolite in humans. Synthesis, analytical data, and determination in serum and urine. Journal of analytical toxicology. Mar-Apr 1995;19(2):91-94.
  4. Schmitt G, Droenner P, Skopp G, Aderjan R. Ethyl glucuronide concentration in serum of human volunteers, teetotalers, and suspected drinking drivers. Journal of forensic sciences. Nov 1997;42(6):1099-1102.
  5. Aderjan RE. Ethyl glucuronide. A non-volatile ethanol metabolite in hair. 1995.
  6. Wurst FM, Seidl S, Alt A, Metzger J. [Direct ethanol metabolite ethyl glucuronide. Its value as alcohol intake and recurrence marker, methods of detection and prospects]. Psychiatrische Praxis. Nov 2000;27(8):367-371.
  7. Wurst FM, Seidl S, Ladewig D, Muller-Spahn F, Alt A. Ethyl glucuronide: on the time course of excretion in urine during detoxification. Addiction biology. Oct 2002;7(4):427-434.
  8. Martin DM, G.E. S, Costantino A. Alcohol Use Can Now be Detected for Days Rather than Hours Using a New Test, Ethyl Glucuronide. 2003; http://www3.firstlab.com/media/16032/EtGFirstLabReport.pdf.
  9. Skipper G. “Urine Luck” Overview of New Drug Testing Technologies and Conundrums. http://gregskippermd.weebly.com/uploads/7/4/7/5/74751/skipper.urine_luck_2014_aaap_meeting.pdf. Accessed March 17, 2015.
  1. Skipper GE, Weinmann W, Thierauf A, et al. Ethyl glucuronide: a biomarker to identify alcohol use by health professionals recovering from substance use disorders. Alcohol Alcohol. Sep-Oct 2004;39(5):445-449.
  2. Jansen M, Bell LB, Sucher MA, Stoehr JD. Detection of Alcohol Use in Monitored Aftercare Programs: A National Survey of State Physician Health Programs. Journal of Medical Licensure and Discipline. 2004;90(2):8-13
  1. Skipper G, Weinmann W, Wurst F. Ethylglucuronide (EtG): A New Marker to Detect Alcohol Use in Recovering Physicians. Journal of Medical Licensure and Discipline. 2004;90(2):14-17.
  2. McGarity TO, Wagner WE. Bending Science: How Special Interests Corrupt Public Health Research. Cambridge, MA: Harvard University Press; 2008.
  3. US Department of Health and Human Services. Mandatory guidelines and proposed revisions to mandatory guidelines for federal workplace drug testing programs: notices. Federal Register. April 13, 2004;69(71):19659-19660.
  4. Clark HW. The role of physicians as medical review officers in workplace drug testing programs. In pursuit of the last nanogram. West J Med. May 1990;152(5):514-524.
  5. Resnick RB, Volavka J, Freedman AM, Thomas M. Studies of EN-1639A (naltrexone): a new narcotic antagonist. Am J Psychiatry. Jun 1974;131(6):646-650.
  6. Sharfstein J. FDA Regulation of Laboratory-Developed Diagnostic Tests: Protect the Public, Advance the Science. JAMA : the journal of the American Medical Association. Jan 5 2015.
  7. Costantino A, Digregorio EJ, Korn W, Spayd S, Rieders F. The effect of the use of mouthwash on ethylglucuronide concentrations in urine. Journal of analytical toxicology. Nov-Dec 2006;30(9):659-662.
  8. Reisfield GM, Goldberger BA, Pesce AJ, et al. Ethyl glucuronide, ethyl sulfate, and ethanol in urine after intensive exposure to high ethanol content mouthwash. Journal of analytical toxicology. Jun 2011;35(5):264-268.
  9. Rosano TG, Lin J. Ethyl glucuronide excretion in humans following oral administration of and dermal exposure to ethanol. Journal of analytical toxicology. Oct 2008;32(8):594-600.
  10. Thierauf A, Gnann H, Wohlfarth A, et al. Urine tested positive for ethyl glucuronide and ethyl sulphate after the consumption of “non-alcoholic” beer. Forensic Sci Int. Oct 10 2010;202(1-3):82-85.
  11. Hoiseth G, Yttredal B, Karinen R, Gjerde H, Christophersen A. Levels of ethyl glucuronide and ethyl sulfate in oral fluid, blood, and urine after use of mouthwash and ingestion of nonalcoholic wine. J Anal Toxicol. Mar 2010;34(2):84-88.
  12. Jatlow P, O’Malley SS. Clinical (nonforensic) application of ethyl glucuronide measurement: are we ready? Alcohol Clin Exp Res. Jun 2010;34(6):968-975.
  13. Administration SAaMHS. The role of biomarkers in the treatment of alcohol use disorders. In: Advisory SAT, ed2006:1-7.
  14. Helliker K. A test for alcohol–and its flaws. The Wall Street Journal2006.
  15. Reisfield GM, Goldberger BA, Crews BO, et al. Ethyl glucuronide, ethyl sulfate, and ethanol in urine after sustained exposure to an ethanol-based hand sanitizer. Journal of analytical toxicology. Mar 2011;35(2):85-91.
  16. Musshoff F, Albermann E, Madea B. Ethyl glucuronide and ethyl sulfate in urine after consumption of various beverages and foods–misleading results? Int J Legal Med. Nov 2010;124(6):623-630.
  17. Thierauf A, Wohlfarth A, Auwarter V, Perdekamp MG, Wurst FM, Weinmann W. Urine tested positive for ethyl glucuronide and ethyl sulfate after the consumption of yeast and sugar. Forensic Sci Int. Oct 10 2010;202(1-3):e45-47.
  18. Helander A, Olsson I, Dahl H. Postcollection synthesis of ethyl glucuronide by bacteria in urine may cause false identification of alcohol consumption. Clinical chemistry. Oct 2007;53(10):1855-1857.
  19. Helander A, Hagelberg CA, Beck O, Petrini B. Unreliable alcohol testing in a shipping safety programme. Forensic science international. Aug 10 2009;189(1-3):e45-47.
  20. Sarkola T, Dahl H, Eriksson CJ, Helander A. Urinary ethyl glucuronide and 5-hydroxytryptophol levels during repeated ethanol ingestion in healthy human subjects. Alcohol and alcoholism. Jul-Aug 2003;38(4):347-351.
  21. Hoiseth G, Bernard JP, Stephanson N, et al. Comparison between the urinary alcohol markers EtG, EtS, and GTOL/5-HIAA in a controlled drinking experiment. Alcohol and alcoholism. Mar-Apr 2008;43(2):187-191.
  22. Wojcik MH, Hawthorne JS. Sensitivity of commercial ethyl glucuronide (ETG) testing in screening for alcohol abstinence. Alcohol and alcoholism. Jul-Aug 2007;42(4):317-320.

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Bent Science and Bad Medicine: The Medical Profession, Moral Entrepreneurship and Social Control

mllangan1 18 Comments

IMG_9005The Medical Profession, Moral Entrepreneurship, and Social Control

Sociologist Stanley Cohen  used the term “”moral panic” to characterize the amplification of deviance by the media, the public, and agents of social control.1  Labeled as being outside the central core values of consensual society, the deviants in the designated group are perceived as posing a threat to both the values of society and society itself.   Belief in the seriousness of the situation justifies intolerance and unfair treatment of the accused.   The evidentiary standard is lowered.

Howard Becker describes the role of “moral entrepreneurs,” who crusade for making and enforcing rules that benefit their own interests by bringing them to the attention of the public and those in positions of power and authority under the guise of righting a society evil. 2

And according to cultural theorist Stuart Hall, the media obtain their information from the primary definers of social reality in authoritative positions and amplify the perceived threat to the existing social order. The authorities then act to eliminate the threat.3  The dominant ideas or ideologies are reproduced by relying on the opinions of the defining authority and then spread through the media. The communal good has been assailed.

As a society governed by organizations, associations,  institutions and regulatory bodies, the medical profession is not immune to “moral panics.”  A threat to patient care or the values of the profession can be identified and amplified.   A buildup of public concern fueled by media attention ensues creating a need for governing bodies to act. Medical Professionalism and the Public Health has been assailed.

Unbeknownst to the general public and most members of the medical profession at large, certain groups have gained tremendous sway within medical society. Through  moral entrepreneurship they have gained authority and become  the primary definers of the governance of the medical profession and the social control of  doctors.  To benefit their own interests they have fostered and fueled “moral panics” and “moral crusades. ” Exhorting authorities to fight these  threats by any means necessary  they have successfully made and enforced rules and  regulations and introduced new definitions and tools with no meaningful resistance or opposition.

The Inquisition did not have to convince  individual citizens or the general public of their beliefs to advance an agenda; just Ecclesiastical and Political Authority.  Similarly, the  “impaired physicians movement” did not have to convince individual doctors or the medical profession of their beliefs  to further a self-serving agenda; just  regulatory and administrative authority.

Addiction Medicine Monopoly, False Authority and Conflicts of Interest

The “impaired physicians movement” can be defined as a group of physicians with alcohol and substance abuse problems who, having found sobriety through 12-step spirituality, banded together to promote the ideology behind their personal  “recovery”  to other doctors and the medical community at large. In the 1980s the movement gained momentum and as their numbers grew  began calling themselves  specialists in “addiction medicine.”  The American Society of Addiction Medicine (ASAM)  is not a true specialty, but a Self-Designated-Practice-Specialty, which simply means that is what they are calling themselves.  It reflects neither knowledge nor expertise..  “Board certification” by the American Board of Addiction Medicine (ABAM) is not recognized by the American Board of Medical Specialties (ABMS).

ABAM certification requires only a medical degree, a valid license to practice medicine, and completion of residency training in ANY specialty.  Addiction Psychiatry, a subspecialty of psychiatry under the American Board of Neurology and Psychiatry  is the only  specialty recognized by the ABMS. and their specialty society is the American Academy of Addiction Psychiatry.

The ASAM is schooled in just one one uncompromising model of addiction with the majority attributing their very own sobriety to that model–the chronic relapsing “brain disease” with lifelong abstinence and 12-step spiritual recovery model.   As the “voice of addiction medicine,” the ASAM has nevertheless defined the dominant treatment paradigm in the United States.   ASAM doctors outnumber addiction psychiatrists by 4:1 and the movement is well funded.   Because addiction is defined as a “disease”, addicts must be “treated” (more often coercive than voluntary), and “cured” (defined as abstinent).  The billion dollar  assessment and treatment industry and the drug and alcohol testing industry  lucratively profits from this model which has grown to monopolize addiction treatment  in the United States.

The goal of the ABAM Foundation is to “gain recognition of Addiction Medicine as a medical specialty by the American Board of Medical Specialties (ABMS).”   A monopoly defined by self-appointed experts without recognized  specialty training will soon likely Robber baron their way to being accepted as  a true specialty.Screen Shot 2015-02-28 at 8.15.35 AM

Physician Health Programs, Regulatory Agencies, and Treatment Centers

Physician Health Programs (PHPs) meet with, assess, and monitor doctors who have been referred to them for substance use or other mental or behavioral health problems. Unless being monitored by one, PHP practices are unknown to most physicians and operate outside the scrutiny of the medical community.  Initially funded by State Medical Societies and staffed by volunteer physicians,  PHPs  served the dual function of helping sick doctors and protecting the public.

As the populations of ASAM physicians proliferated  in the 1980s, many  joined their state Physician Health Programs. PHP doctors who did not agree with the ASAM groupthink were gradually removed  and they  organized under the Federation of State Physician Health Programs (FSPHP).  Other ASAM physicians found employment at treatment centers as staff physicians and medical directors.

The FSPHP cultivated a relationship with the  Federation of State Medical Boards (FSMB) and the state PHPs formed alliances with their  state medical boards. Promoting themselves as offering “treatment” rather than”punishment” they offered an alternative to disciplinary action.  They then began promoting their successful outcomes  in rehabilitating “impaired physicians”,  and this history can be seen by examining the archives of the Journal of Medical Regulation and similar  publications.  In 1995 the   Washington  PHP claimed a success rate of  95.4%,   Tennessee  claimed 93% and Alabama 90%.

Part of this success was attributed  to the specialized  treatment centers for doctors directed by their ASAM colleagues such as  Ridgeview Institute in Atlanta created by G. Douglas Talbott.  Talbott, who helped organize and serve as past president of the ASAM claimed a 92.3 percent recovery rate. He also put forth a Medical Urban Legend–the proposition that doctors were a different species, separate from the rest of society, who needed special treatment three times longer than anyone else.  Amazingly, this dicto simpliciter argument that can, in fact, be refuted simply by pointing it out  was allowed to enter regulatory medicine unopposed.  Simply because, sadly, no one ever pointed out the logical fallacy. It is now entrenched.    Three months or more of treatment is  standard of care for our profession. They did this by getting medical boards and the FSMB to accept fantasy as fact by relying on board members tendency to accept expert evidence at face value.

Physicians are unique only insofar as the unique elements required of the profession to become and be a physician such as going to medical school and completing the required board examinations.  That’s it.    I implore anyone to put forth any sound argument based on science and evidence that justifies a thrice lengthy stay in medical professionals.  Not gonna happen.   Thought stopping memes and logical fallacy is the best they have to offer.  And, unfortunately this type of  rabbling gibberish cuts the mustard in the regulatory medicine venue.   A “low-bar” evidentiary standard is not the problem.  If you look at the documentary evidence from a medico-historical perspective there never was a bar.  The FSMB has essentially given the impaired physicians movement carte blanche authority and unrestrained managerial prerogative.  A bar never even existed.  It’s a laissez-faire Lord of the Flies free-for-all.    The logical fallacy of appeal to authority–illegitimate and irrational authority.  Bamboozled by smoke and mirrors.

A 1995 issue of the FSMB publication  The Federal Bulletin: The Journal of Medical Licensure and Discipline contains reports on eight  separate state  PHPs.   The “almost 90% success rate” was  applauded by the editor, who added  “cooperation and communication between the medical boards and the physician health programs must occur in an effort to protect the public while assisting impaired physicians in their recovery.”   And more recent reports suggest PHPs   reduce malpractice claims. They are now being promoted as a replicable model  to be used in other populations.

The problem is no one bothered to examine the methodology to discern the validity of these claims.  There has been no critical analysis or Cochrane type review of any of these studies which are invariably small, methodologically flawed, and biased.

The FSMB has accepted them as  expert authority and  their authoritative opinion as fact.  It  is this acceptance of faith without objective assessment that has allowed the ASAM and FSPH to advance their agenda. By  confusing ideological opinion  with professional knowledge, the FSMB and state Medical Boards have acted as willing gulls each step of the way. No counter-forces existed.  And they still don’t.   Junk science and unvalidated neuropsychological testing is used by these groups unconstrained and willfully.  There is no regulation, oversight, or accountability.  They are using polygraph testing (despite the AMA’s previous public policy statement deeming it junk) to both condemn “disruptive” surgeons and deem convicted pedophiles fit to return to work.  They have introduced junk-science in drug and alcohol testing and unvalidated “neuropsychological” testing to detect “character-defects” by getting regulatory agencies to accept the validity of these tests not by the Scientific Method or Evidence Based Research but by (to coin a term) “Regulatory Sanctification”

To paraphrase one FSPHP member,   “Who needs evidence-based medicine when the boards have already accepted these tests as valid?”  Who indeed?

The ideological bias and financial conflicts of interest between PHPs and the  treatment centers was also not recognized. It still isn’t.  The  spotlights are apparently all  on Big Pharma  in this regard.    Some sunlight needs to be exposed in the direction of the billion dollar drug and alcohol testing and assessment industry as well.

Doctors  were held at Ridgeview three times longer than the rest of the population (and at three times the cost)  under threat of loss of licensure.   Although there is no evidence base or plausible explanation why an entire profession would have a three-times  longer length of stay than the rest of the population this continues to be the reality. There is no choice.

in 2011 The ASAM issued a Public Policy Statement on coordination between PHPs, regulatory agencies, and treatment providers recommending  that  only “PHP approved” treatment centers be used in the assessment and treatment of doctors.  It specifically excludes non “PHP -recognized” facilities.  And what defines a “PHP approved” treatment center?    In addition to finding essentially no oversight by the state medical society and medical board, a recent audit of the  North Carolina PHP found financial conflicts of interest and no  documented criteria for selecting the out of state treatment centers they used.  The common denominator the audit missed was that the 19  “PHP-approved” centers were all ASAM facilities just like Ridgeview whose medical directors can be seen on this list.

The appeal to authority logical fallacy has enabled the FSPHP to become the expert authority on physician impairment through the eyes of the medical boards.  It has also allowed them to increase their scope.

The FSMB House of Delegates adopted an updated Policy on Physician Impairment at their 2011 annual meeting distinguishing “impairment” and “illness”  stating that:

“Regulatory Agencies should recognize the PHP as their expert in all matters relating to licensed professionals with ‘potentially impairing illness.'”

According to the FSPHP, physician illness and impairment exist on a continuum with illness typically predating impairment, often by many years.”

The policy extends PHP authority to cover physical illnesses affecting cognitive, motor, or perceptive skills, disruptive physician behavior, and “process addiction” (compulsive gambling, compulsive spending, video gaming, and “workaholism”). It also defines “relapse without use” as “behavior without chemical use that is suggestive of impending relapse.”

G. Douglas Talbott defines  “relapse without use”  as  “emotional behavioral abnormalities” that often precede relapse or “in A A language –stinking thinking.”  AA language has entered the Medical Profession and no one even blinked.  It will get worse.

The ASAM has  monopolized addiction treatment in the United States.   It has imposed  it on doctors through the FSPHP.  The FSPHP political apparatus exerts a monopoly of force. It selects who will be monitored and dictates every aspect of what that entails.  It is a, in fact, a  rigged game.

Inherent in this model is the importance of external control.  It gives them power to exert control over the individual regardless of whether they need to be treated.

By bamboozling regulatory medicine this was accomplished.    And the maintenance of this relationship is necessary as this  presentation  by an FSPHP physician  warns, “guard this relationship jealously.”

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Moral Panics and Moral Crusades

By introducing and fueling moral panics the ASAM/FSPHP political apparatus has been able to expand in both scope and power.

The Medscape article “Drug Abuse Among Doctors:  Easy, Tempting, and Not Uncommon” published in the “Business of Medicine” section in January 2014 is characteristic example of the authoritative opinion, propaganda, and misinformation spun to maintain a pervasive climate of fear. Proof by anecdote.  Physicians are “5 times as likely as the general public to misuse prescription drugs” according to Lisa Merlo, PhD.  “Given the epidemic of prescription addiction sweeping the nation, that’s a grim statistic.”

Described as a “researcher at the University of Florida’s Center for Addiction Research and Education,” Merlo’s research involving 55 doctors being monitored by their state Physician Health Program published in the Journal of Addiction Medicine in October 2013 found “most physicians who abuse prescription drugs” do so to “relieve stress and physical or emotional pain.”  Nowhere is it mentioned on Medscape that Merlo is the Director of Research for the Florida state PHP Professionals Research Network.   Physician access to medications through prescriptions,  “networks of professional contacts, and proximity to hospital and clinic supplies” gives them “rare access to powerful, highly sought-after drugs” says Marvin D. Seppala, chief medical officer at Hazelden.  This access “sets them apart” and “not only foment a problem” but”perpetuate it” says Seppala.  “Access “becomes an addict’s top priority” and they “will do everything in their power to ensure it continues.”  

“They’re often described as the best workers in the hospital,” he says. “They’ll overwork to compensate for other ways in which they may be falling short, and to protect their supply. They’ll sign up for extra call and show up for rounds they don’t have to do.”-Dr. Marvin D. Seppala

Physicians are intelligent and skilled at hiding their addictions, he says. Few, no matter how desperate, seek help of their own accord.”  In reality this is absurd.  And if you look at any of the current “moral panics” that are being used to suggest random suspicion-less drug testing of all doctors or promoting the Physician Health Programs as the “New Paradigm” you will inevitably find a doctor, just like Marv Seppala who is on this list as  an author or interviewee.  It is a given.

The terms  “impaired physician” and  the “disruptive physician”  are used as labels of deviancy.  As deviants who allegedly threaten the very core of medicine (patient care) and  the business of medicine (profit)  they must be stopped at all costs.   Belief in the seriousness of the situation justifies intolerance and unfair treatment.  The evidentiary standard is lowered.  Aided by a  “conspiracy of silence” among doctors in which impaired colleagues are not reported  necessitates identification of them by any means necessary.   Increase the grand scale of the hunt.

In this way these front-groups have successfully acted as moral entrepreneurs to make and enforce rules and put forth new definitions and mandates that serve their own interests.     A retrospective non -blinded non-randomized cohort study with serious underlying methodological errors involving 904 physicians being monitored by PHPs is now being used to “set the standard for recovery.”

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Across the Country doctors are going to the media,  law enforcement, the AGO, and the ACLU only to be turned a deaf ear.   Many consider this a “parochial” issue best handled by the medical community. Doctors reporting crimes are turned back over to the very perpetrators of the crimes.   The Medical Societies and professional organizations contribute to the problem by willful ignorance.   Accusations are used to disregard the claims of the accused.   It is a system of institutional injustice that is driving many doctors to suicide.  Hopeless, helpless, and feeling entrapped many are taking this route.  And no one is talking about it.   This cannot be avoided any longer.

The next target is the “aging physician.”   And as they have done with the “impaired” and “disruptive” physician” the FSPHP and their affiliates are setting the stage for another “moral crusade.”

  1. Cohen S. Folk Devils and Moral Panics: The Creatio of the Mods and Rockers (New Edition). Oxford, U.K.: Martin Robertson; 1980.
  2. Becker H. Outsiders: Studies in the Sociology of Deviance. New York: Free Press; 1963.
  3. Hall SC, Critcher C, Jefferson T, Clark J, Roberts B. Policing the Crisis: Mugging, the State, and Law and Order. London: Macmillan; 1978.

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Junk-Science in the Medical Profession: The Resurgence of Polygraph “Lie-Detection” in an age of Evidence-Based Medicine

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Disrupted Physician

33755_1527129670651_5081648_n Circa 1995

The article below was published in the now defunct magazine Gray Areas almost twenty years ago. (Vol. 4, No. 1, Spring 1995 pp. 75-77).   Antipolygraph.og founder George Maschke noted in 2008 that article “makes a good introduction to the pseudoscience of polygraphy” and “the criticisms of polygraphy remain valid today.”  They remain valid in 2014.

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The Art of Deception: Polygraph Lie Detection

By Michael Lawrence Langan, M.D.

I’d swear to it on my very soul, If I lie, may I fall down cold.”

– Rubin and Cherise
(Hunter/Garcia)

The accuracy of polygraphic lie detection is slightly above chance. Nevertheless, State and local police departments and law enforcement agencies across the United States are devoted proponents of this unscientific and specious device. In addition, the American public seems to lend an implicit credence to the “lie detector” as evinced by its ubiquitous use on television crime shows and…

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